Human Subjects in Research

Welcome to the Department for Human Research Protections & Institutional Review Boards

The University of Toledo affirms the need for academic freedom in the conduct of research and the value of well-designed, responsible activities that involve human subjects. At the same time it recognizes the basic responsibility to assure the protection of any human subjects and has established the Department for Human Subjects Research (DHRP) to oversee that responsibility.  The DHRP provides guidance to researchers and administrative support for the Biomedical and Social Behavioral and Educational Institutional Review Boards.
 
Basic Principles
 
Investigations conducted at The University of Toledo are expected to embody the following basic principles in agreement with The Belmont Report,  The Declaration of Helsinki, The University of Toledo’s Federalwide Assurance for Protection of Human Subjects, Terms of Assurance and the “Common Rule” 45 CFR 46, Subpart A: and 45 CFR 46 Subparts B, C and D.
    1. Participation of human beings as subjects must be voluntary, i.e., must occur as a result of free choice, without compulsion or obligation, based upon disclosure of relevant information in a comprehensible way.

    2. Adequate standards of informed consent must always be utilized.


    3. Adequate provision must be made to protect the privacy of subjects and maintain the confidentiality of information.

       
    4. The selection of subjects must be based upon fair procedures and not overburden, over-utilize, or unfairly favor, or discriminate against, any particular subject pool.

       
    5. Any risks to the subject must be carefully minimized, and adequately balanced against potential benefits. Proper precaution should be taken and plans made to deal with emergencies that may develop in the course of even seemingly routine activities.  


    6. Approval for any human subject research must be obtained from one of the UT IRBs prior to the initiation of any research activities

Federalwide Assurance (FWA) for the Protection of Human Subjects 

The University of Toledo’s FWA, and the corresponding Terms of Assurance provide the framework for the human research subject protection program and associated institutional review boards at UT. Because compliance with the FWA and Terms of Assurance is vital to prevent federally imposed restrictions or suspension of all human subject research at UT, everyone involved in human subject research should have a solid understanding of the content and importance of these documents. Please take a moment to review the discussion of UT’s FWA and Terms of Assurance.

 

Last Updated: 5/26/15